Just saw and wanted to share. Apparently they are recalling them, but not wanting to replace it if you already have one in you.   Hmmm??? Not good enough for new patients, but we're not going through the expense of taking them out.  Sounds like a pile of crap to me!

                              http://realizemysuccess.com/VoluntaryRecall.htm

Please share with your band friends

VOLUNTARY RECALL OF REALIZE® ADJUSTABLE GASTRIC BAND

CINCINNATI - October 13, 2010 - Obtech Medical Sàrl, a medical device manufacturer, and Ethicon Endo-Surgery (EES), in cooperation with the U.S. Food and Drug Administration (FDA), have initiated a voluntary worldwide recall of existing inventory of adjustable gastric band systems sold under the brand name: REALIZE® Adjustable Gastric Bands. There is no action required for patients who already have received these gastric bands, and removal (explantation) of the gastric band is not required.

The voluntary recall was undertaken due to reports of the potential for the Tubing Strain Relief, a small (2 centimeter) flexible sheath on the band's Injection Port, to slide out of its intended position. In these rare cases, the Tubing Strain Relief may slide along the catheter tubing that connects to the Injection Port. If this happens, the Tubing Strain Relief can no longer aid in preventing kinking where the tubing connects to the port. The Tubing Strain Relief was an enhancement made to the gastric band system to address tube kinking, a complication common to all gastric bands.

Movement of the Tubing Strain Relief is highly unlikely to cause any serious injury or adverse health consequences and it rarely affects the band's function. In the extremely rare instance when tube kinking occurs at the Injection Port, the physician might be unable to adjust fluid volume within the gastric band, which may require additional surgery to correct. The reported incidence of the Tubing Strain Relief sliding out of its intended position is less than 1 in 1,000. The reported incidence of tube kinking at the port related to the Tubing Strain Relief sliding out of position is 1 in 10,000. There have been no reported cases of gastric band removal due to the Tubing Strain Relief sliding out of position.

As part of our ongoing commitment to improve the safety and effectiveness of the band, EES identified this issue as part of the company's continuous improvement program and developed an enhanced design of the component that was approved by the FDA. Hospitals and clinics will receive the enhanced replacement product upon returning the recalled product. All new orders will receive the updated product.

About the Realize® Adjustable Gastric Band
The Realize® Adjustable Gastric Band is used in one type of weight-loss surgery. It contains two main components: the first is a fluid-filled balloon that is placed around the stomach; the second is an injection port to adjust the degree of fluid in the band. Thin flexible tubing connects these two main components. The recall involves an ancillary component called the Tubing Strain Relief.

If surgeons or patients have any additional questions, they may call our Customer Support Center at 1-866-REALIZE (1-866-732-5493) for more information.

About Ethicon Endo-Surgery
Ethicon Endo-Surgery develops and markets advanced medical devices for minimally invasive and open surgical procedures, focusing on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, gynecology and surgical oncology. More information can be found at  www.ethiconendosurgery

Wow LaShelle! I hadn't heard of that. Thanks for posting. I have a Lap Band and not Realize but I will share the info.

Yes, this has been floating about for a week or so on the band boards - I completely agree with your last two sentences! But at least I suppose that if anyone does have an issue, they can come back to this briefing and make sure they get all costs covered.

Kate

Kate if I had one in me, I'd be mad as hell and demanding a revision! Especially if I was having any complications. I mean if they know something is faulty with it now, who is to say 5-10 years from now when your's breaks they will even still be in business. Something like this could ruin a company, especially when Lap band still has the  majority of the market.

R-banders need to get behind this and make them stand behind their product and take care of you. This should not be swept under the rug.

Realize is a part of Johnson and Johnson, so don't think they will go out of business anytime soon.  Apparently, this is some older inventory and the % of bands that have a problem is small...
This was posted on the Realize site last week and I posted it on the boards then and everyone can make their own decision as to how to proceed.  I am not too concerned at this point, and even if their was an issue it is with a small part of the tubing that is designed to prevent kinks, not the band itself, so any repair will be relatively easy and not require the band to be removed.
I don't think this is a reason to have a "call to arms"....here is the link to my post and the link to the Realize site notifying us of the recall.

http://www.obesityhelp.com/forums/LapBand/4258888/Realize-Recall-Update/#35034097

I'm lapbanded so not directly affected. But I think that what i would want is some sort of guarantee that if things went wrong in the future (which was linked to this fault) , I would expect them to cover it. It seems to be a very specific possible complication (potential kinking of the tubing) and so it should be easy to say if it is the defect which caused any problem.

The reports seem to show that the chances of it going wrong are not high and so I would not want another surgery as a just-in-case measure.

Kate

Yikes.  So this is essentially Realize saying, "My bad."?

Seems to me they're sying we broke it but we aint gonna fix it.

This might be a reall unpopular stance but... if you had one of these in you, would you really want to undergo another surgery to prevent the 1/1000 chance that your tubing might be defective? Doesn't it make more sense to wait and see if you have problems with your tubing and then get it replaced if you do? I've heard of people needing minor surgeries to fix ports that have moved, flipped, tubes coming detached and all sorts of things that just happen because it's an implanted device, it's not going to work 100% of the time in 100% of people, just a fact of life.  The surgical complication risks of getting opened up again just to take it out are probably much more serious than having a potentially kinky tube in you.

Just saying...